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Commonwealth of Pennsylvania

Pennsylvania CodeTitle 28. Health & Safety

Department of HealthChapter 25. Controlled Substances, Drugs,

Devices, and CosmeticsSubchapter B. Hearing Aid Sales and Registration

(10/04)

Subchapter B. HEARING AID SALES AND REGISTRATION

25.201. Application.25.202. Definitions.25.203. Advisory Council.25.204. Application for and renewal of registration.25.205. Additional registration requirements.25.206. Examinations.25.207. Categories of registrations: fee schedule.25.208. Display of registration certificates; offices.25.209. Facilities, procedures and instrumentation.25.210. Receipt, disclosure agreement and money back guarantee to pur-

chaser – purchaser protection.25.211. Medical recommendations; waiver form.25.212. Medical recommendations by examining physicians.25.213. Consumer review.25.214. Recordkeeping.25.215. Denial, revocation or suspension of registrant’s certificate.25.216. Continuing education requirements.25.217. Approval of continuing education programs.25.218. Credit for continuing education.25.219. Responsibilities of persons offering continuing education pro-

grams. 25.220. Rights to enter, inspect and obtain records.25.221. Exceptions.

Authority

The provisions of this Subchapter B issued under The Hearing Aid Sales Registration Law (35P. S. §§ 6700-101 – 6700-802), unless otherwise noted.

Source

The provisions of this Subchapter B adopted August 25, 1978, 8 Pa.B. 2343; amended May28, 2004, effective May 29, 2004, 34 Pa.B. 2808, unless otherwise noted.

§ 25.201. Application.(a) Scope. This subchapter applies to all persons engaged in the business

of selling or fitting hearing aids in this Commonwealth; except that physi-cians and audiologists are exempted from all provisions regarding hearingaid fitters.

(b) Authority. This subchapter is adopted under the act.

Notes of Decisions

Since the legislature obviously believes that the license already held by physicians and audi-ologists is adequate proof of their competence to fit patients with hearing aids, they are notrequired to take a qualifying examination prior to obtaining a hearing aid dealers certificate.

Ch. 25-B HEARING AID SALES AND REGISTRATION 28

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Pennsylvania Hearing Aid Dealers Association, Inc. v. Department of Health, 417 A.2d 1340(Pa. Cmwlth. 1980).

§ 25.202. Definitions.The following words and terms, when used in this subchapter, have the

following meanings, unless the context clearly indicates otherwise:Act – The Hearing Aid Sales Registration Law (35 P. S. §§ 6700-101 –

6700-802).Advertise and any of its variants – The use of a newspaper, magazine or

other publication, book, notice, circular, pamphlet, letter, handbill, poster,sign, placard, label, tag, window display, store sign, radio, televisionannouncement, Internet, or other means or methods employed to bring to theattention of the public the practice of selling or fitting hearing aids.

Audiologist – A person who holds a current license as an audiologistissued by the State Board of Examiners in Speech-Language and Hearing,or a person who is permitted to practice audiology pursuant to an exemptionto the audiologist licensure requirement under section 6(b) of the Speech-Language and Hearing Licensure Act (63 P. S. § 1706(b)).

Authorized representative – A person who is authorized by law to make adecision, required pursuant to this subchapter, for a hearing aid user orprospective hearing aid user.

Business of selling hearing aids – (i) Selling, leasing or offering for sale or lease new, used or recondi-

tioned hearing aids exclusive of parts, attachments or accessories, at retail,either as exact replacements for damaged or worn out units or writtenspecifications provided by an audiologist, otologist or otolaryngologist.

(ii) The term does not include fitting or the practice of fitting and sell-ing hearing aids. Continuing education program – A program approved by the Department

for credit towards the continuing education requirements for the renewal ofthe registration certificate of a hearing aid fitter.

Conviction – A plea or verdict of guilty, or a conviction following a pleaof nolo contendere to a charge of a crime involving moral turpitude.

Department – The Department of Health of the Commonwealth. Fitting – Includes the physical acts of adjusting the hearing aid to the indi-

vidual, taking audiograms, making ear molds, advising the individual withrespect to hearing aids, making audiogram interpretations and assisting in theselection of a suitable hearing aid to sell a hearing aid.

Hearing aid – A wearable instrument or device designed or offered to aidor compensate for impaired human hearing together with any parts, attach-ments or accessories for those instruments or devices, including ear moldsbut excluding batteries and cords.

Hearing aid dealer – A person engaged in the business of selling hearingaids.

28 § 25.202 DEPARTMENT OF HEALTH Ch. 25-B

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Hearing aid fitter – An individual engaged in the practice of fitting andselling hearing aids.

Hearing aid user – An individual who uses a hearing aid.Practice of fitting and selling hearing aids – Those practices used solely

for making selections, adaptations and sales of hearing aids.Prospective hearing aid user – An individual who is considering buying a

hearing aid or whose hearing is being evaluated by a registrant. Purchaser – An individual who has agreed to purchase a hearing aid from

a registrant. Registrant – A hearing aid dealer or fitter holding a current certificate of

registration. Secretary – The Secretary of Health of the Commonwealth. Sponsor – An individual registered in this Commonwealth as a hearing aid

fitter who agrees to supervise an apprentice hearing aid fitter. Used hearing aid –

(i) A hearing aid that has been worn for any period of time by a user.(ii) A hearing aid is not a used hearing aid if it has been worn only by

a prospective user as part of a bona fide hearing aid evaluation conductedin the presence of the registrant or an individual selected by the registrantand authorized by law to assist the prospective user in making such anevaluation.

§ 25.203. Advisory Council.(a) The Advisory Council (Council) will be composed as provided for

under section 201 of the act (35 P. S. § 6700-201).(b) It will be the duty of the Council to advise the Secretary, to the best

of its ability, on the administration of the act.(c) The Council will hold at least one annual meeting at a time and place

designated by the Secretary for the purpose of providing information andadvice to the Department.

(d) A Council member may convey the impression, either publicly orprivately, that the member is acting officially for the Council only with priorauthorization from the Council.

§ 25.204. Application for and renewal of registration.(a) Application. An application for registration or renewal of registra-

tion as a hearing aid dealer, hearing aid fitter, apprentice hearing aid fitter ortemporary hearing aid fitter can be obtained from the Division of HomeHealth, Pennsylvania Department of Health, 132 Kline Plaza, Suite A,Harrisburg, Pennsylvania 17104.

(b) Apprentice hearing aid fitter. A completed application for registra-tion as an apprentice hearing aid fitter shall be filed with the Department atleast 30 days before the fitter’s examination that the applicant intends totake, together with a check, money order or other approved method of pay-ment as the Department publishes in a notice in the Pennsylvania Bulletin,

Ch. 25-B HEARING AID SALES AND REGISTRATION 28 § 25.203

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in the amount of $50. An additional $150 shall be paid before taking the fit-ter’s examination. The application fee is not refundable, but the $150 fee forthe examination will be refunded to an applicant who is found to be ineligi-ble to take the examination.

(c) All other registrations. A completed application for any registrationcertificate, other than a registration certificate as an apprentice hearing aidfitter, may be filed at any time, together with a check, money order or otherapproved method of payment as the Department publishes in a notice in thePennsylvania Bulletin, in the amount of the appropriate application fee.

(d) Renewal of current certificate. A registrant shall apply to renew acurrent registration certificate by March 16 prior to the certificate’s expira-tion, by submitting a completed renewal application, available from theDepartment, along with the renewal fee of $100. To renew a hearing aid fit-ter’s registration certificate, the applicant shall also demonstrate satisfactionof the continuing education requirements under § 25.216 (relating to contin-uing education requirements).

(e) Renewal of expired certificate. An expired registration certificatemay be renewed within 5 years after its expiration or inactive date by filingan application for renewal, with payment of the renewal fee, and payment ofthe delinquency fee if the application is received more than 30 days after theexpiration date. To renew an expired hearing aid fitter’s registration certifi-cate, the applicant shall also demonstrate satisfaction of the continuing edu-cation requirements under § 25.216.

(f) Renewal of fitter’s temporary registration certificate and apprenticecertificate. Upon application, the Secretary may renew a temporary certifi-cate or apprentice certificate for a period which shall expire 30 days after thenext available fitter’s qualifying examination has been given. The Secretarywill not issue more than two renewals of these certificates, except upon peti-tion of an applicant for good and sufficient cause shown. An applicant maypetition the Department for an additional renewal. The petition shall includethe reasons for which the additional renewal is requested. An applicant shallsend a petition for additional renewal to the Division at the address given insubsection (a). The Department will then decide whether to issue the renew-al.

(g) Late application for renewal. A person who files for renewal of aregistration certificate after March 16 may not receive the renewal before theregistration certificate expires.

Cross References

This section cited in 28 Pa. Code § 25.205 (relating to additional registration requirements);28 Pa. Code § 25.206 (relating to examinations); and 28 Pa. Code § 25.208 (relating to dis-play of registration certificates; offices).


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§ 25.205. Additional registration requirements.(a) Hearing aid dealers. No requirement is imposed in addition to those

imposed under § 25.204(c) (relating to application for and renewal of regis-tration).

(b) Hearing aid fitters. A hearing aid fitter shall pass the qualifyingexamination as provided by the act.

(c) Reciprocal registration – certificate by endorsement.(1) An applicant for registration to practice as a hearing aid dealer or

as a hearing aid fitter who is licensed or registered in any other state,which has requirements equal to or greater than those in thisCommonwealth for registration as a hearing aid dealer or fitter and whichmaintains reciprocal practice privileges with this Commonwealth, may begranted a registration certificate by endorsement by the Secretary. Beingqualified to apply for a hearing aid fitter’s registration certificate byendorsement relieves the applicant from having to take the qualifyingexamination otherwise required under the act.

(2) In all other respects, the applicant for a registration certificate byendorsement shall be registered in the same manner and meet the samerequirements as other registrants.

(3) If the Commonwealth does not maintain reciprocal practice privi-leges with a state in which a person is registered or otherwise authorizedto function as a hearing aid fitter or dealer, the person may apply for atemporary registration certificate under subsection (e).(d) Apprentice registration. Apprentice registration shall conform to the

following:(1) An applicant for registration as an apprentice hearing aid fitter

shall have a sponsor responsible for the training and supervision of theapplicant.

(2) An application shall be accompanied by a statement of the spon-sor:

(i) Setting forth the type of supervision which shall be given theapplicant.

(ii) Providing an outline of the training program to be followedin preparing the applicant for examination. The training program shallinclude education and training in at least the following areas:

(A) The anatomy and physiology of the ear.(B) The function of hearing aids.(C) The grounds for revocation or suspension of a certifi-

cate of registration, or probation of a registrant, under the act.(D) The violations and penalties under the act.(E) The procedures and use of equipment established by

the Department for the fitting and selling of hearing aids.(F) The taking of ear mold impressions.(G) The medical and rehabilitation facilities for children

and adults that are available in the areas served.


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(H) The criteria for medical referral when found to existeither from observation by the registrant or on the basis of infor-mation furnished by the prospective hearing aid user, to includethose criteria in § 25.211(d) (relating to medical recommenda-tions; waiver forms).(iii) Providing the registration number of the sponsor.

(3) An apprentice hearing aid fitter desiring to change sponsors shallfurnish the Department a sworn or affirmed request giving reasons for thechange and a sworn or affirmed statement from the new sponsor settingforth the information required by paragraph (2), and accompanied by theapprentice’s certificate of registration. An affirmed statement may begiven in any form so long as it is in writing, signed, and contains a state-ment to the effect that it is truthful.

(4) A sponsor desiring to terminate responsibilities with regard to anapprentice shall give the apprentice 10 days written notice of the reasonsfor the action and shall notify the Department at the same time by certi-fied mail. (e) Temporary registration. Temporary registration shall conform to the

following:(1) A temporary fitter’s registration certificate will be issued to an

applicant who satisfactorily demonstrates having been engaged in the fit-ting and selling of hearing aids at an established place of business in astate other than this Commonwealth for 2 years within a 5-year periodimmediately before making application and who otherwise fulfills therequirements of the act and this subchapter.

(2) The temporary registrant shall take the hearing aid fitter’s exami-nation to qualify for a regular hearing aid fitter’s registration certificate.

(3) The temporary registration certificate shall expire 30 days after theadministration of the qualifying examination that the temporary registranttakes. The temporary registrant shall take the qualifying examination noearlier than 90 days after the date the temporary registration certificatewas issued, and no later than 1 year after the date the temporary registra-tion certificate was issued.

Notes of Decisions

Since the legislature obviously believes that the license already held by physicians and audi-ologists is adequate proof of their competence to fit patients with hearing aids, they are notrequired to take a qualifying examination prior to obtaining a hearing aid dealers certificate.Pennsylvania Hearing Aid Dealers Association, Inc. v. Department of Health, 417 A.2d 1340(Pa. Cmwlth. 1980).

§ 25.206. Examinations.(a) An examination to obtain registration as a hearing aid fitter shall be

held at least twice each year, at a time and place to be fixed by the Secretaryat least 45 days before the examination date.


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(b) The date of an examination may be obtained by writing to theDivision at the address given in § 25.204(a) (relating to application for andrenewal of registration), by checking the Department’s website atwww.health.state.pa.us, or by phone or e-mail to the Division.

(c) The passing grade on an examination will be determined by theSecretary.

§ 25.207. Categories of registrations; fee schedule.(a) A registration certificate, other than a temporary or apprentice regis-

tration certificate, shall expire at midnight of April 15 of each year, if notrenewed.

(b) For a hearing aid dealer, the initial registration fee is $200 if theDepartment issues the registration certificate between April 15 and October14, and $100 if the Department issues the registration certificate betweenOctober 15 and April 14. The annual renewal fee is $100 for both dealers andfitters.

(c) For a hearing aid fitter’s registration certificate, the initial registra-tion fee is $200, $150 of which will be refunded if the applicant is ineligibleto take the qualifying fitter’s examination. The annual renewal fee is $100.

(d) For a registration certificate by endorsement the fees shall be thesame as in subsection (b).

(e) For a temporary hearing aid fitter’s registration certificate, the initialregistration fee is $200, $150 of which is for the examination. A refund ofthe $150 will be made if the applicant is ineligible to take the qualifyingexamination for a fitter’s registration certificate. Instead of paying the full$200 when making the application, the applicant may pay $50 when makingthe initial application, and $150 before taking the examination for the firsttime. The renewal fee is $100.

(f) For an apprentice fitter’s registration certificate, the fee is $50 plusan additional $150 before the apprentice takes the fitter’s examination. Therenewal fee is $100.

(g) For a duplicate or replacement registration certificate, the fee is $10.The registrant shall obtain a duplicate certificate upon the loss of an originalcertificate or for a branch office. The registrant shall obtain a replacementregistration certificate upon a name change by the person holding a certifi-cate.

(h) The fee to retake the fitter’s examination for an applicant who haspreviously failed the examination is $50.

(i) A delinquency fee will be assessed if an applicant applies for renew-al of a registration certificate after May 15. The delinquency fee is $50.

(j) For renewal of a suspended registration certificate, the fee is $100plus the delinquency fee if one has otherwise accrued.


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§ 25.208. Display of registration certificates; offices.(a) A registrant shall display the dealer’s or fitter’s registration certifi-

cate at the place of business listed in the registrant’s application.(b) If a registrant maintains more than one place of business within this

Commonwealth, the registrant shall apply for a duplicate registration certifi-cate for each branch office. The registrant shall display the appropriate dupli-cate registration certificate in each office.

(c) The place of business identified in a registrant’s application shall bean office at a fixed location. An office which is part of a building normallyused as a residence shall be in a space set aside for office purposes only.

(d) A registrant shall file notice of a change in the registrant’s place ofbusiness with the Department at least 10 work days before the change bywriting to the Department at the address given in § 25.204(a) (relating toapplication for and renewal of registration).

(e) A registrant shall make the registration certificate available forinspection on request of any client, prospective client, Department employ-ee or law enforcement official.

§ 25.209. Facilities, procedures and instrumentation.(a) Facilities. A registrant shall engage in the practice of fitting or sell-

ing a hearing aid only if the registrant provides:(1) An appropriate test area, the ambient noise level of which shallhave a documented readout of 55 dB or lower on the A scale of a soundlevel meter.(2) A selection of hearing aid models, supplies and accessories to pro-vide for the immediate needs of hearing aid users or prospective hearingaid users.(b) Procedures. A registrant shall satisfy the following:

(1) The registrant shall sell a hearing aid only if within 6 monthsbefore the sale an examination of the prospective hearing aid user wasconducted using pure tone air conduction, bone conduction and speechaudiometry tests. This requirement does not apply when the registrant isreplacing a hearing aid with another of the same make, model andresponse. The registrant shall sell a hearing aid replacing another of thesame make, model and response only if within 12 months before the salean examination of the prospective hearing aid user was conducted usingpure tone air conduction, bone conduction and speech audiometry tests.The registrant shall verify that the tests were performed by an individualauthorized by law to do so. The registrant may rely on a representation bythe physician, audiologist or fitter who performed or supervised the teststhat the individual who performed the tests was authorized to do so.

(2) The registrant shall:(i) Perform air conduction tests for hearing level thresholds at

frequencies of 250 Hz, 500 Hz, 1,000 Hz, 2,000 Hz, 4,000 Hz and6,000 Hz or 8,000 Hz, with masking if necessary.


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(ii) Perform bone conduction tests for hearing level thresholds atfrequencies of 500 Hz, 1,000 Hz, 2,000 Hz and 4,000 Hz, with mask-ing if necessary.

(iii) Maintain records of the test results for each ear for 7 years.(iv) Perform a speech reception or speech awareness threshold

test using an electronic speech audiometer with head or insert earphones.

(v) Perform a word discrimination or other speech intelligibilitytest for conversational level speech using an electronic speechaudiometer with head or insert ear phones.(3) The registrant shall sell a hearing aid only if the hearing aid is fit-

ted to the wearer to ensure physical and operational comfort and improve-ment in hearing function is demonstrated and documented in at least oneof the following areas: speech detection, speech awareness levels, speechintelligibility, orientation or speech reception threshhold.(c) Instrumentation. A registrant shall satisfy the following:

(1) All test instruments shall be calibrated once each year or moreoften if necessary to meet current American National Standards Institutestandards for pure tone and speech audiometry as identified by 1996A.N.S.I. standards or applicable succeeding A.N.S.I. standards.

(2) Instruments transported to test sites shall be calibrated to the stan-dard set forth in paragraph (1) every 6 months, or more frequently asneeded.

(3) Calibration shall be performed by a qualified individual other thanthe owner.

(4) A signed certificate identifying the most recent date of calibrationshall be maintained for inspection by the Department.

Cross References

This section cited in 28 Pa. Code § 25.214 (relating to recordkeeping).

§ 25.210. Receipt, disclosure agreement and money back guarantee topurchaser – purchaser protection.

(a) Receipt. Upon the sale of a hearing aid, the registrant shall providethe purchaser a signed receipt. The receipt may be made out on more thanone sheet of paper and shall contain the following:

(1) The date of sale.(2) The make, model and serial number or, if no serial number is

applicable, an identification number of the hearing aid.(3) The address of the principal place of business of the registrant.(4) If the hearing aid is used or reconditioned, a statement which pro-

vides that information and which meets the requirements of § 25.215(23)(relating to denial, revocation or suspension of registrant’s certificate).

(5) The registrant’s registration certificate number.


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(6) The terms of any guarantee or express warranty made to the pur-chaser with respect to the hearing aid.

(7) A copy of the written forms as required by § 25.211 (relating tomedical recommendations; waiver forms).

(8) A statement on or attached to the receipt, in no smaller than 10point type, as follows:

‘‘The purchaser has been advised at the outset of his relationship withthe hearing aid dealer that any examination or representation made by aregistered hearing aid dealer and fitter in connection with the practice offitting and selling of this hearing aid, is not an examination, diagnosis orprescription by a person licensed to practice medicine in thisCommonwealth and therefore must not be regarded as medical opinion.’’

(9) A statement on the face of the receipt, in no smaller than 10 pointbold type, as follows: ‘‘If your rights are violated, you may contact theState Bureau of Consumer Protection, the Pennsylvania Department ofHealth in Harrisburg, or your local district attorney.’’(b) Disclosure agreement and money back written guarantee. Before the

provision of any service incidental to or connected with the potential sale ofa hearing aid, the registrant shall provide a disclosure agreement and moneyback written guarantee to the prospective hearing aid user or authorized rep-resentative, and shall explain it in detail in accordance with subsection (c).This shall be in 10 point type or larger, and may be made out on more thanone sheet of paper, but shall employ the following format or be on a formapproved by the Department:


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HEARING AID DISCLOSURE AGREEMENT/MONEY BACK GUARANTEE (Business Name)_______________________(Business Address)_______________________________________ Telephone No. ( ) _______________________ PART A.

Description of services

included in fitting procedure

or process, and sale and

delivery of hearing aid.

FEE (State whether fee is waived if hearing aid purchased)

REFUNDABLE

(Upon return of hearing aids)

NOT

REFUNDABLE

THIS DISCLOSURE AGREEMENT WAS PROVIDED, PARTS A AND B WERE EXPLAINED, AND PART A (FEES FOR SERVICES NOT PART OF THE PRICE OF THE HEARING AID) WAS COMPLETED AT _________(time) ON ___________________(date), BEFORE ANY SERVICES WERE PROVIDED. PART B (CANCELLATION FEES THAT WILL BE INCURRED IF A HEARING AID IS RETURNED UNDER THE 30-DAY MONEY BACK GUARANTEE BELOW), WAS COMPLETED AND EXPLAINED AFTER SERVICES WERE PROVIDED AND BEFORE ANY PAYMENT WAS MADE. IF PART B IS NOT COMPLETED, IT IS BECAUSE A HEARING AID WAS NOT RECOMMENDED OR NOT DESIRED. NOTHING IN THIS DISCLOSURE AGREEMENT SHALL RELIEVE A REGISTRANT OF THE OBLIGATION TO REFUNDALL OR PART OF THE ABOVE FEES, INCLUDING THOSE LISTED AS NOT REFUNDABLE, IF A COURT DETERMINES THAT THE REGISTRANT HAS VIOLATED A PENNSYLVANIA CONSUMER PROTECTION LAW IN THE SALE OR FITTING OF THE HEARING AID (OR SIMILAR DEVICE) AND IF THE COURT ORDERS SUCH REFUND. ___________________________________ _________________________________ Customer’s Signature Registrant’s Signature

PART B.

HEARING AIDS &

ACCESSORIES

DESCRIPTION of

GOODS – include make, model, serial number(s)

PRICE REFUNDABLE

(upon return of hearing aid)

NOT

REFUNDABLE

(Cancellation Fee)

Right Hearing

Aid(s)

Left

Accessories (Describe, if applicable)

TOTAL

Total maximum Cancellation Fee is lesser of 10% or $150 per hearing aid including accessories.

30 Day Money Back Guarantee: If a hearing aid is returned within 30 days of date of delivery in the same condition, ordinary wear and tear excluded, you are entitled to a refund of the portion of the purchase price of the hearing aid and accessories as itemized on the receipt and above, less the cancellation fee stated above. If a cancellation fee is imposed the nonrefundable amount for each aid and accessories cannot exceed 10% of the purchase price of the hearing aid and accessories or $150.00 per aid and accessories, whichever is less. You will, however, be responsible for all nonrefundable service fees listed in Part A. If you cancel your order prior to delivery, you are entitled to full refund of the purchase price of the aid and accessories, and a full refund for services not yet rendered.

__________________________ ____________________ Customer’s Signature Date and time of Sale

__________________________ ___________________ Registrant’s Signature Registration No.

___________________________ DATE of DELIVERY __________________________

Customer’s Signature or Initials

(c) Additional responsibilities of registrant with respect to the disclo-sure agreement/money back guarantee.

(1) Before providing any services incidental to the possible sale of ahearing aid to the prospective hearing aid user, the registrant shall explainPart A of the disclosure agreement/money back guarantee to the prospec-tive hearing aid user or authorized representative and shall complete PartA. The registrant shall also give a preliminary explanation of Part B,including any cancellation fees that may be retained if a purchaser decidesto return a hearing aid. The registrant shall include in Part A a completedescription of what the fitting procedure or process includes, and shallitemize and disclose fees associated with the fitting procedure or processand the sale and delivery of the hearing aid. For each service provided, theregistrant shall identify by dollar amount the portion of the fee that isrefundable and the portion that is not refundable. If a fee will be waivedif a hearing aid is purchased, that shall be stated. If the registrant chargesno fees for services, the registrant shall note that in Part A.

(2) After Parts A and B have been explained and Part A has been com-pleted, the registrant shall have the prospective hearing aid user or author-ized representative complete the time and date lines provided under PartA. The prospective hearing aid user or authorized representative and reg-istrant shall also sign under Part A when appropriate.

(3) After completing the necessary testing, if it is determined that ahearing aid will be recommended, the registrant shall explain and com-plete Part B, itemizing any cancellation fee associated with the sale anddelivery of a hearing aid and its accessories by designating that amount as‘‘not refundable.’’ Part B shall be fully explained and completed beforeany payment is made. If Part B becomes inapplicable due to a decision bythe registrant, prospective hearing aid user or authorized representativenot to proceed further after testing, the disclosure agreement/money backguarantee need not be fully completed. The registrant shall provide a copyof the partially completed disclosure agreement/money back guarantee tothe prospective hearing aid user or authorized representative.

(4) If the registrant and the prospective hearing aid user or authorizedrepresentative decide to proceed, the registrant shall explain the 30-daymoney back guarantee. If the prospective user or authorized representa-tive decides to purchase a hearing aid, the registrant shall have the pur-chaser sign the second signature line on the disclosure agreement/moneyback guarantee and complete the line for date and time of sale, and shallalso sign when appropriate.

(5) The registrant may revise the relevant portion of the disclosureagreement/money back guarantee form to disclose the registrant’s policyof offering a money back guarantee return period longer than 30 days. Themoney back guarantee shall be for at least 30 days from the date of deliv-ery.


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(6) After the disclosure agreement/money back guarantee is fullycompleted except for the date of delivery block and the hearing aid serialnumbers, the registrant shall provide a copy of it to the hearing aid user orauthorized representative.

(7) At the time the hearing aid is delivered to the hearing aid user orauthorized representative, the registrant shall ensure that the signature orinitials of the user or authorized representative is obtained and the date ofdelivery and serial number are inserted in the block or section providedfor that purpose on the disclosure agreement/money back guarantee. Afterthe block is completed with the initials or signature and date and the seri-al number is inserted, the registrant shall provide a copy of the completeddisclosure agreement/money back guarantee to the purchaser.

Cross References

This section cited in 28 Pa. Code § 25.214 (relating to recordkeeping).

§ 25.211. Medical recommendations; waiver forms.(a) Except when selling a replacement of a worn out or damaged hear-

ing aid, when selling a hearing aid for the use of a prospective hearing aiduser who is 19 years of age or older, a registrant shall either obtain for theprospective user a medical recommendation that complies with § 25.212(relating to medical recommendations by examining physicians), or ensurethat the prospective user or authorized representative signs a waiver form asprovided under section 403 of the act (35 P. S. § 6700-403). The waiverform shall be prepared and used as follows:

(1) The waiver form shall be in 10 point type or larger.(2) The waiver shall be read to the prospective hearing aid user orauthorized representative and explained in a manners that the individ-ual is not encouraged to waive a medical examination and so that theindividual will be thoroughly aware that signing the waiver will not bein the prospective hearing aid user’s best interest.(3) The waiver form shall read as follows:

I have been advised that my best interests would be served if I had a medicalexamination by an otologist or otolaryngologist or any licensed physicianbefore my purchase of a hearing aid.

(Registrant’s Name) has fully and clearly informed me of the value of suchmedical examination. After such explanation, I voluntarily sign this waiver.I choose not to seek a medical examination before the purchase of the hear-ing aid.

(Signature of Registrant)

(Address of Registrant)


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(b) When selling a replacement of a worn out or damaged hearing aidfor the use of a prospective hearing aid user who is 18 years of age or older,a registrant shall either obtain for the prospective user a medical recommen-dation that complies with the requirements of § 25.212, or ensure that theprospective user or authorized representative signs a legally proper waiver ofthe medical examination. For purposes of this subsection, a legally properwaiver includes a medical waiver form as provided under section 403 of theact and described in subsection (a), or a Federal medical waiver form asapproved by the Food and Drug Administration of the United StatesDepartment of Health and Human Services.

(c) Except when a registrant is selling a hearing aid to replace an iden-tical hearing aid, the registrant may sell a hearing aid for the use of aprospective user 18 years of age or younger only if the registrant obtains amedical recommendation that complies with the requirements of § 25.212and is signed by a physician specializing in otolaryngology or otology. Whenselling an identical replacement hearing aid for the use of an individual under18 years of age, the registrant shall obtain a medical recommendation thatcomplies with the requirements of § 25.212.

(d) Before the sale of a hearing aid a registrant shall inform the prospec-tive hearing aid user or authorized representative, in writing, that it would bein the best interest of the prospective hearing aid user to consult a physicianspecializing in or qualified to deal with diseases of the ear if the prospectivehearing aid user has any of the following conditions:

(1) Visible congenital or traumatic deformity of the ear.(2) Active drainage from the ear within the previous 90 days or a his-

tory of this symptom.(3) Sudden or rapidly progressive hearing loss within the previous 90

days or a history of this symptom.(4) Acute or chronic dizziness.(5) Unilateral hearing loss of sudden or recent onset within the previ-

ous 90 days.(6) Visible evidence of cerumen accumulation or a foreign body in the

ear canal.(7) Significant air-borne gap of 15dB or greater at 500 Hz, 1000 Hz

and 2000 Hz.(8) Pain in the ear within the previous 90 days.

Cross References

This section cited in 28 Pa. Code § 25.205 (relating to additional application requirements);28 Pa. Code § 25.210 (relating to receipt to purchaser – purchaser protection); 28 Pa. Code §25.213 (relating to consumer review); and 28 Pa. Code § 25.214 (relating to recordkeeping).

§ 25.212. Medical recommendations by examining physicians.(a) Whenever a medical examination is performed under the act or

Federal requirements, before fitting and selling a hearing aid the registrant


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shall ensure that a medical recommendation has been signed by the examin-ing physician, within 180 days before the sale, on a form which includes thefollowing statement or its equivalent:

I have medically evaluated the hearing ability of

(Patient’s Name)

and a hearing aid may be beneficial to this person.

(Signature of Physician)

(Date of Evaluation)

(b) If the prospective hearing aid user is 18 years of age or younger, theregistrant shall ensure that the prospective user’s date of birth has beenincluded on the medical recommendation form.

Cross References

This section cited in 28 Pa. Code § 25.211 (relating to medical recommendations; waiverforms); and 28 Pa. Code § 25.214 (relating to recordkeeping).

§ 25.213. Consumer review.(a) Before signing a waiver form under § 25.211 (relating to medical

recommendations; waiver forms) and before the sale of a hearing aid to orfor the use of a prospective hearing aid user, the registrant shall:

(1) Provide the prospective hearing aid user or authorized representa-tive with a copy of the User Instructional Brochure for the hearing aid thathas been or may be selected for the prospective user.

(2) Review the content of the User Instructional Brochure with theprospective hearing aid user or authorized representative orally or in thepredominant method of communication used during the sale.

(3) Give the prospective hearing aid user or authorized representativean opportunity to read the User Instructional Brochure.(b) If goods or services having a sale price of $25 or more are sold or

contracted to be sold to a purchaser as a result of or in connection with a con-tact with or call on the purchaser at the purchaser’s residence, the purchasermay avoid the contract or sale by notifying the registrant of that decision, inwriting, within 3 full business days following the day on which the contractor sale was made and by returning or holding available for return to the reg-istrant, in its original condition, any merchandise received under the contractor sale. The notice of rescission is effective when deposited in the UnitedStates mail or when service is made in another manner which gives the reg-istrant notice of rescission. These and additional provisions relating to thesale of goods in the purchaser’s home, including specific items which shall


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be included on the purchase receipt, are made a part of this section by incor-poration of section 7 of the Unfair Trade Practices and Consumer ProtectionLaw (73 P. S. § 201-7).

§ 25.214. Recordkeeping.A registrant shall, upon the consummation of a sale of a hearing aid, keep

and maintain records in the registrant’s office or place of business at alltimes. These records shall be kept for 7 years and shall include the follow-ing:

(1) Results of all testing conducted under § 25.209 (relating to facil-ities, procedures and instrumentation). The minimum acceptable testrecords shall be records of:

(i) Pure tone tests including air and bone conduction with mask-ing where appropriate, and the ambient noise level of the test area.

(ii) Speech reception threshold expressed in decibels of hearinglevel.

(iii) Most comfortable level expressed in decibels.(iv) Uncomfortable (tolerance) level expressed in decibels.(v) Word discrimination test results expressed in percentage

indicating the test words used, presentation level, masking level (ifapplicable), and signal to noise ratio (if applicable).

(2) A copy of the written receipt, disclosure agreement and money backguarantee required by § 25.210 (relating to receipt, disclosure agreementand money back guarantee to purchaser – purchaser protection).

(3) The written physician’s recommendation required by § 25.212(relating to medical recommendations by examining physicians) or the waiv-er form required by § 25.211 (relating to medical recommendations; waiverforms).

§ 25.215. Denial, revocation or suspension of registrant’s certificate.The Secretary may deny, suspend or revoke a registration certificate pro-

vided under the act or the Secretary may impose conditions of probationupon a registrant for any of the following causes:

(1) Gross incompetency which includes the improper or unnecessaryfitting of a hearing aid.

(2) Conviction of a felony or misdemeanor involving moral turpitude.(3) Obtaining a registration certificate by fraud or deceit.(4) Using the term ‘‘doctor’’ or ‘‘physician’’ or ‘‘clinic’’ or ‘‘audiolo-

gist’’ or any derivation thereof as part of the firm name under which theregistrant fits and sells hearing aids, unless authorized by law.

(5) Fraud or misrepresentation in the repair, fitting or selling of a hear-ing aid.

(6) Employing a person to perform a function within the scope ofpractice of a hearing aid fitter who is not authorized by law to perform thefunction.


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(7) Habitual intemperance.(8) Gross immorality.(9) Permitting another person to use the registration certificate for any

purpose, except permitting an audiologist or physician employed by theregistrant to sell hearing aids for the registrant.

(10) Violating or, with notice or knowledge permitting an employee toviolate, the act or this subchapter.

(11) A cause which would be a ground for denial of an application fora registration certificate.

(12) Having been enjoined from violating a provision of the UnfairTrade Practices and Consumer Protection Law (73 P. S. §§ 201-1 – 209-6) or being subject to a final order of the Federal Trade Commission, theDepartment, or the Food and Drug Administration of the United StatesDepartment of Health and Human Services, concerning the sale or offer-ing for sale of an unsafe, unhealthful or worthless hearing device or forengaging in conduct which has the tendency to mislead or deceive.

(13) Using, causing or promoting the use of any advertising matter,promotional literature, testimonial, guarantee, warranty, label, brand,insignia or any other representation, however disseminated or published,that is misleading, deceiving, improbable or untruthful, such as a misrep-resentation relating to:

(i) The grade, quality, quantity, origin, novelty, price, dealercost, terms of sale, use, construction, size, composition, dimensions,type, design, development, visibility, durability, performance, fit,appearance, efficacy, benefits, cost of operation, resistance to climaticconditions, or physiological benefits of a hearing aid or the psycholog-ical well-being induced by a hearing aid.

(ii) A service or adjustment offered, promised, or supplied to apurchaser of a hearing aid, or the fee associated with the service oradjustment.(14) Making a representation that a hearing aid is ‘‘guaranteed,’’ with-

out clear and conspicuous disclosure of:(i) The nature and extent of the guarantee.(ii) A material condition or limitation of the guarantee which is

imposed by the guarantor.(iii) The manner in which the guarantor will perform thereunder.(iv) The identity of the guarantor, with disclosure, if applicable,

that any guarantee made by the registrant which is not backed up by themanufacturer is offered by the registrant only.

(v) The meaning of ‘‘life’’ or ‘‘lifetime’’ to clarify whether itrefers to the life of the purchaser, the product, or otherwise, wheneverrepresentations are made that a hearing aid is ‘‘guaranteed for life’’ orhas a ‘‘lifetime guarantee.’’(15) Making a guarantee, warranty, or promise which, under normal

conditions, is impractical of fulfillment or which is for a period of time or


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of a nature that may cause a purchaser to believe that the hearing aid hasa greater degree of service ability, durability or performance capability inactual use than is true.

(16) Making a misrepresentation as to the character of the businessconducted by the registrant. Unless it is true, a registrant may not repre-sent directly or indirectly through the use of any word or term, in the cor-porate or trade name, in advertising, or otherwise, that the registrant ownsor maintains a laboratory devoted to hearing aid research, testing, experi-mentation or development. A registrant may not misrepresent in any othermaterial respect the character, extent or type of business conducted by theregistrant.

(17) Causing deception that services or advice of a physician were usedin the design or manufacture of hearing aids. Unless it is true, a registrantmay not represent, directly or by implication, that the services or adviceof a physician have been used in the designing or manufacturing of hear-ing aids. The prohibitions of this paragraph are applicable to the use of theterms ‘‘doctor,’’ ‘‘physician,’’ ‘‘otologist’’ or ‘‘otolaryngologist,’’ to theuse of any abbreviations, variations or derivatives of those terms; and tothe use of any symbol, depiction, or representation having a medical con-notation.

(18) Making a deceptive representation as to the visibility or the con-struction of a hearing aid. A registrant may not do any of the following:

(i) Represent, directly or by implication, through the use of suchwords or expressions as ‘‘invisible,’’ ‘‘hidden,’’ ‘‘hidden hearing,’’‘‘completely out of sight,’’ ‘‘conceal your deafness,’’ ‘‘hear in secret,’’‘‘unnoticed even by your closest friends,’’ ‘‘no one will know you arehard of hearing,’’ ‘‘your hearing loss is your secret,’’ ‘‘no one needknow you are wearing a hearing-aid,’’ ‘‘hidden out of sight when insert-ed in the ear canal’’ or by any other words or expressions of similarimport, that any hearing aid, device, or part is hidden or cannot be seenunless it is hidden or cannot be seen.

(ii) Represent directly or by implication that a hearing aid utiliz-ing bone conduction has a specified feature such as the absence of any-thing in the ear or leading to the ear, or the like, without disclosingclearly and conspicuously that the instrument operates on the bone-conduction principle and that, in many cases of hearing loss, this typeof instrument may not be suitable.(19) Making an advertisement or other representation which may have

the tendency or effect of misleading or deceiving a purchaser or prospec-tive purchaser to believe that a hearing aid or device or part or accessorythereof is a new invention or involves a new mechanical or scientific prin-ciple, when that is not true. Representations of the following or similartypes, when not fully justified by the facts, are among those prohibited bythis paragraph: ‘‘amazing new discovery,’’ ‘‘revolutionary new inven-tion,’’ ‘‘radically new and different,’’ ‘‘sensational new laboratory devel-


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opment,’’ ‘‘remarkable new electronic device,’’ ‘‘brand new invention,’’‘‘marvelous new hearing invention,’’ ‘‘new scientific aid’’ and ‘‘miracle.’’

(20) Misrepresenting the commercial nature of the registrant’s busi-ness. A registrant may not represent, directly or by implication, that acommercial hearing aid establishment is a governmental or public one oris a nonprofit medical, educational or research institution, through the useof a term having a medical, professional or scientific connotation, such as‘‘Hearing Center,’’ ‘‘Hearing Institute,’’ ‘‘Hearing Bureau,’’ ‘‘HearingClinic,’’ ‘‘State’s Hearing Clinic,’’ or ‘‘State’s Speech and HearingCenter.’’ Nothing in this paragraph precludes a registrant from represent-ing, if true, that the registrant owns, operates or controls a ‘‘Hearing AidCenter’’ or from using other words or expressions which clearly and non-deceptively identify the registrant’s establishment as a commercial hear-ing aid enterprise.

(21) Making a deceptive advertisement of a hearing aid part, accessoryor component. A registrant may not use or cause to be used any type ofadvertising or promotional literature depicting or describing only a singlepart, accessory or component of a hearing aid or device, such as a batteryon the finger or a transistor held in the hand, in a manner that may havethe tendency to mislead or deceive a purchaser or prospective purchaserto believe that the part, accessory or component is all that must be wornor carried.

(22) Making a deceptive testimonial or other endorsement. A registrantmay not advertise or otherwise represent that:

(i) A particular individual, organization or institution endorses,uses or recommends the registrant’s hearing aids or devices when thatis not true.

(ii) A particular individual wears the registrant’s hearing aids ordevices when that is not true.(23) Making a representation either directly or indirectly that a hearing

aid or part thereof is new, unused or rebuilt when that is not true.(i) In the marketing of a used hearing aid or a hearing aid which

contains used parts, a registrant shall make full and nondeceptive dis-closure of the fact in advertising and promotional literature relating tothe product on the container, box or package in which the product ispacked or enclosed. The required disclosure may be made by use ofwords such as ‘‘used,’’ ‘‘second-hand,’’ ‘‘repaired’’ or ‘‘rebuilt,’’whichever applies to the product involved, and it shall appear on a tagphysically attached to a hearing aid.

(ii) A registrant may not misrepresent the identity of therebuilder of a hearing aid. If the rebuilding of a hearing aid was doneby other than the original manufacturer, a registrant shall disclose thefact wherever the original manufacturer is identified.(24) Doing any of the following:


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(i) Representing or using a seal, emblem, shield or otherinsignia which represents, directly or by implication that a hearing aidor device has been tested, accepted or approved by an individual, con-cern, organization, group or association unless it is true and unless thehearing aid or device has been used in a manner as will reasonablyensure the quality and performance of the instrument in relation to itsintended use and the fulfillment of a material claim made, implied orintended to be supported by the representation or insignia.

(ii) Representing that a hearing aid or device tested, accepted orapproved by an individual, concern, organization, group or associationhas been subjected to a test based on a more severe standard of per-formance, workmanship and quality than is true.

(iii) Making any other false, misleading or deceptive representa-tion respecting the testing, acceptance or approval of a hearing aiddevice by an individual, concern, organization, group or association. Itis not necessary for an individual hearing aid or device to be tested ifthe method employed is a sample testing and full and nondeceptive dis-closure of this fact is given in advertising and otherwise.

(iv) Making a false, misleading or deceptive representationregarding the practice of another registrant or the quality of a hearingaid product made by a hearing aid manufacturer, which enhances or islikely to enhance the registrant’s business as a repairer, fitter or sellerof hearing aids.(25) Doing any of the following:

(i) Imitating or simulating the trademark, trade name, brand orlabel of a competitor which may have the tendency or effect of mislead-ing or deceiving a purchaser or prospective purchaser.

(ii) Using in advertising the name, model name or trademark ofa particular manufacturer of hearing aids in a manner that implies arelationship with the manufacturer that does not exist or which other-wise may mislead or deceive a purchaser or prospective purchaser.

(iii) Using a trade name, corporate name, trademark or other des-ignation which may have the tendency or effect of misleading ordeceiving a purchaser or prospective purchaser as to the name, natureor origin of a hearing aid or of a material used therein or which is false,deceptive or misleading in another material respect.(26) Advertising a particular model, type or kind of hearing aid for sale

when a purchaser or prospective purchaser responding to the advertise-ment cannot purchase or is dissuaded from purchasing the advertisedmodel, type or kind, if it is established that the purpose of the advertise-ment is to obtain prospects for the sale of a different model, type or kindthan that advertised.

(i) In determining whether there has been a violation of thisparagraph, consideration will be given to acts or practices indicatingthat the offer was not made in good faith for the purpose of selling the


25-B-20

advertised product but was made for the purpose of contacting prospec-tive purchasers and selling them a product or products other than thatoffered. Among acts or practices which will be considered in makingthat determination are the following:

(A) The creation, through the initial offer or advertisement,of a false impression of the product offered in a material respect.

(B) The refusal to show, demonstrate or sell the productoffered in accordance with the terms of the offer.

(C) The disparagement, by acts or words, of the productoffered or the disparagement of the guarantee; credit terms; oravailability of service, repairs or parts or the disparagement inanother respect, in connection with it.

(D) The showing, demonstrating and in the event of sale,delivery of a product which is unusable or impractical for the pur-pose represented or implied in the offer.

(E) The refusal, in the event of sale of the product offered,to deliver the product to the purchaser within a reasonable timethereafter.

(F) The failure to have available a quantity of the adver-tised product at the advertised price sufficient to meet reasonablyanticipated demands.(ii) It is not necessary that each act or practice set forth in sub-

paragraph (i) be present to establish that a particular offer violates thisparagraph; any one will be sufficient.(27) Failing to furnish evidence of the required continuing education or

truthful information regarding the continuing education secured whenapplying for renewal of a registration certificate as a hearing aid fitter.

Cross References

This section cited in 28 Pa. Code § 25.210 (relating to receipt to purchaser – purchaser pro-tection).

§ 25.216. Continuing education requirements.(a) General requirements. Except as provided in subsection (d), the con-

tinuing education requirement for renewal of a hearing aid fitter’s registra-tion certificate is 20 hours of continuing education credit in the 2 yearsimmediately preceding the expiration of the current registration certificate.If the applicant for renewal has had a registration certificate for less than 2years, the required number of continuing education hours shall be calculatedby prorating the number of credit hours required over a 2-year period by thenumber of months in which the applicant for renewal had the registrationcertificate which is about to expire. Only months in which the applicant hadthe registration certificate for at least 15 days shall be considered in the cal-culations.


25-B-21

(b) Requirements for renewal of an expired registration certificate.Except as provided in subsection (d), the continuing education requirementfor renewal of a hearing aid fitter’s registration certificate that has expired is20 hours of continuing education credit in the 2 years immediately preced-ing the filing of the application for renewal, provided that the application forrenewal is filed within 5 years after expiration of the previous registrationcertificate. If more than 5 years have passed since the registration certificateexpired, the registration certificate may not be renewed. Instead, the individ-ual shall repeat the hearing aid fitter’s certification examination and satisfyother requirements then in effect for an original hearing aid fitter’s registra-tion certificate.

(c) Requirements for renewal of a suspended registration certificate.The continuing education requirement for renewal of a hearing aid fitter’sregistration certificate which has been suspended is the same as in subsec-tions (a) and (d). If the individual does not satisfy the continuing educationrequirement during the period in which the hearing aid fitter’s registrationcertificate is suspended, the suspended registration certificate shall be con-sidered to have expired, and the continuing education requirements in sub-section (b) shall apply for renewal of the expired registration certificate.

(d) Phase-in requirements. The first 2-year period for which continuingeducation requirements shall be required began on April 15, 2003.

(e) Subject matter requirements. Any subject matter that contributesdirectly to the professional competence, skills and education of a hearing aidfitter is acceptable subject matter for a continuing education program. Atleast one-half of all continuing education credit hours by which the hearingaid fitter seeks to qualify for renewal of the registration certificate shall besecured in some combination of the following core subject matter: hearingevaluation, hearing instrumentation technology, ear mold technology, hear-ing aid repair and maintenance, technical devices to assist the hearing-impaired, psychology of the hearing-impaired, and office procedures andcompliance with the act.

Source

The provisions of this § 25.216 adopted May 28, 2004, effective May 29, 2004, 34 Pa.B.2808.

Cross References

This section cited in 28 Pa. Code § 25.204 (relating to application for and renewal of regis-tration); and 28 Pa. Code § 25.217 (relating to approval of continuing education programs).

§ 25.217. Approval of continuing education programs.(a) A person may apply to the Department for approval of a continuing

education program by submitting to the Department an application on a formsupplied by the Department. The applicant shall supply the informationrequested in the application, including specification of whether the program


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is fully or partially devoted to any of the core subjects specified in §25.216(e) (relating to continuing education requirements). The Departmentwill grant approval of a continuing education program and designate whetherthe program is assigned full or partial credit in one of the core subjects, if theapplicant satisfies the Department that the program the applicant will offerwill meet the following minimum standards:

(1) The program shall contribute directly to the professional compe-tence, skills and education of a hearing aid fitter.

(2) The program instructors shall possess the necessary practical andacademic skills to conduct the program effectively.

(3) Program materials shall be clear, informative, grammatical, care-fully prepared, readable and distributed to attendees at or before the timethe program is offered whenever practical.

(4) The program shall be presented by a responsible instructor who isexperienced and knowledgable in the subject matter being taught, in a set-ting that is conducive to learning the material being taught, including anynecessary equipment and facilities, and is devoted to the educational pur-pose of the program.

(5) The program shall be open to persons who have a current, sus-pended or expired hearing aid fitter’s registration certificate.(b) Approval of a continuing education program shall be effective for 3

years.(c) If renewal of the Department’s approval of a continuing education

program is desired, at least 90 days before expiration of the 3-year period theperson who offered the program shall apply to the Department to renew theDepartment’s approval of that program. The criteria and process applicableto the Department’s initial approval of a continuing education program shallapply to renewal of the approval of that program.

Source


§ 25.218. Credit for continuing education.(a) Credit hour. A hearing aid fitter shall receive 1 hour of credit for

each 50 minutes of instruction in a continuing education program presentedin a classroom setting. Credit may not be given if attendance or other partic-ipation in the program is not adequate to meet the educational objectives ofthe program as determined by the person offering the program. For complet-ing a continuing education program that is not presented in a classroom set-ting, the hearing aid fitter shall receive the number of credit hours assignedto the program by the Department.

(b) Program completion. A hearing aid fitter shall receive no credit fora continuing education program not completed, as evidenced by satisfactionof the check-in/check-out process for a continuing education program pre-


25-B-23

sented in a classroom setting and the continuing education report verifyingthat the hearing aid fitter completed the program, both of which are submit-ted to the Department by the person who offered the program. The programshall also not be considered completed if the hearing aid fitter does not sat-isfy other program completion requirements imposed by this subchapter andthe continuing education provider.

(c) Continuing education credit for instruction. A hearing aid fitter shallreceive credit equal to the number of hours served as an instructor in a con-tinuing education program approved by the Department, or in a program thatsatisfies requirements for initial certification as a hearing aid fitter, exceptthat only half of the credit hours necessary for renewal of a hearing aid fit-ter’s registration certificate may be obtained through serving as an instructor.The remaining credits necessary to renew a certificate shall be obtainedthrough attendance at continuing education programs.

(d) Repeat completion or teaching of a continuing education program.The Department will not accept more than one completion or teaching of acontinuing education program for credit toward renewal of a fitter’s registra-tion certificate, but will accept a subsequent completion or teaching of thesame continuing education program for a subsequent renewal of a fitter’sregistration certificate.

(e) Continuing education credit through endorsement. A hearing aid fit-ter who attends or teaches a continuing education program offered outsidethis Commonwealth may apply to the Department to receive credit for theprogram. The hearing aid fitter shall have the burden of demonstrating to theDepartment that the course meets standards substantially equivalent to thestandards imposed in this subchapter. The Department will assign credit tothe program, including the possibility of no credit or partial credit, basedupon considerations of whether the program bears entirely upon appropriatesubject matter and whether the method of presenting the program meets stan-dards substantially equivalent to those prescribed in this subchapter.

(f) Continuing education credit assigned to self-study courses. Creditmay be sought from the Department for a self-study continuing educationprogram. The hearing aid fitter shall submit an application to the Departmentto approve the self-study program for credit before commencing the programand shall supply the Department with the materials the Department requeststo conduct the evaluation, which may include any of the materials used in thecourse. The Department will assign credit to the program based upon consid-erations of whether the program addresses appropriate subject matter andwhether the method of completing the program meets standards substantial-ly equivalent to those prescribed in this subchapter. The Department mayrequire modifications to the proposed self-study as a precondition to approv-ing it for credit. If the materials are unavailable to the fitter prior to takingthe course, the fitter may apply to the Department for credit after completingit. However, the Department reserves the right to disapprove the course for


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credit after it has been completed if it does not meet the standards prescribedin this subchapter.

(g) Continuing education credit assigned to courses not presented in aclassroom setting. A hearing aid fitter shall be awarded credit for completinga continuing education program without the hearing aid fitter physicallyattending the program in a classroom setting, provided the program has beenapproved by the Department for credit when presented in that manner.

(h) Resolution of discrepancies. The Department will resolve all dis-crepancies between the number of continuing education credits reported andthe number of continuing education credits a hearing aid fitter alleges to haveearned. To help resolve disputes, the hearing aid fitter should retain the orig-inal certificate of completion of a continuing education program if a certifi-cate of completion has been received by the hearing aid fitter.

Source


§ 25.219. Responsibilities of persons offering continuing educationprograms.

(a) Record of attendance. A person who offers a continuing educationprogram shall maintain a record of attendance for a program presented in aclassroom setting by maintaining a check-in/check-out process approved bythe Department, and shall assign at least one person to ensure that all indi-viduals attending the course check in when entering and check out whenleaving. If an individual enters a course after the starting time, or leaves acourse before the finishing time, the assigned person shall ensure that thetime of arrival or departure is recorded for the individual.

(b) Reporting attendance. A person who offers a continuing educationprogram shall report to the Department, in the manner and format prescribedby the Department, attendance at each continuing education program pre-sented in a classroom setting.

(c) Course evaluation. A person who offers a continuing education pro-gram shall develop and implement methods to evaluate the program to deter-mine its effectiveness. The methods of evaluation shall include providing aprogram evaluation form to each person who attends the continuing educa-tion program, and requesting each person to complete the form.

(d) Record retention. A person who offers a continuing education pro-gram shall retain the completed program evaluation forms and the check-in/check-out record for a program presented in a classroom setting. The per-son shall retain the records for at least 4 years from the presentation of theprogram.

(e) Providing records. A person who offers a continuing education pro-gram shall promptly provide the Department with complete and accuraterecords relating to the program as requested by the Department.


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(f) Program not presented in a classroom setting. A person who offersa continuing education program shall be exempt from the requirements ofsubsections (a) and (b) for a program which is not presented in a classroomsetting, if the program is approved by the Department for credit when pre-sented in that manner. When presenting the program to the Department forapproval for credit, the person shall present a procedure for monitoring, con-firming and reporting hearing aid fitter participation in a manner thatachieves the purposes of subsections (a) and (b).

(g) Monitoring responsibilities. A person who offers a continuing edu-cation program shall ensure that the program was presented in a manner thatmet all of the educational objectives for the program, and shall determinewhether each hearing aid fitter who enrolled in the program met the require-ments of this subchapter and of the continuing education program to receivecredit for completing the program.

(h) Program completion. A person who offers a continuing educationprogram shall report to the Department, in a manner and format prescribedby the Department, completion of a continuing education program by a hear-ing aid fitter who completes the program, and shall identify to theDepartment a hearing aid fitter who seeks credit for a program but who didnot meet the requirements of the program or this subchapter to receive con-tinuing education credit. The person who offers a continuing education pro-gram shall also provide a hearing aid fitter who completes the program witha document certifying completion of the program.

Source


§ 25.220. Right to enter, inspect and obtain records.Upon request of a Department representative during regular and usual

business hours, or at other times when that representative possesses a reason-able belief that a violation of this subchapter may exist, and upon the repre-sentative presenting documentation to identify himself as a representative ofthe Department, a registrant or person who offers a continuing educationprogram shall:

(1) Produce for inspection equipment and supplies maintained pur-suant to this subchapter.(2) Produce for inspection, permit copying and provide within a rea-sonable period of time, records maintained under this subchapter.

Source



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§ 25.221. Exceptions.The Department may grant an exception to a requirement of this subchap-

ter for good cause shown, except for a statutory requirement that is repeatedin this subchapter.

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25-B-27

Com

monw

ealth of Pennsylvania

Departm

ent of Health

Hearing A

id Program

132 Kline P

laza, Suite AH

arrisburg, PA17104

(717) 783-8078

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